Description

Vanafil Related Compound 1 is a high-purity chemical reference standard, identified by CAS NO 759408-08-7, primarily used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products. It serves as an essential impurity marker and analytical standard for the development and validation of methods related to the active pharmaceutical ingredient, Vardenafil. Industries that require this material include pharmaceutical R&D, quality control laboratories, and contract manufacturing organizations (CMOs) focused on producing generic or branded medications.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify and quantify related substances in Vardenafil API and finished dosage forms.
• Analytical Method Development & Validation: A critical component for developing and validating HPLC, UPLC, or GC methods to meet ICH Q2(R1) and USP guidelines.
• Quality Control & Assurance: Employed in routine QC testing to monitor batch-to-batch consistency and ensure product purity specifications are met.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurity identification.
• Stability Studies: Used as a benchmark to track the formation of degradation products under various stress conditions.
• Research & Development: Facilitates chemical research into the metabolism, synthesis pathways, and degradation mechanisms of PDE5 inhibitors.

Basic Information

Product Name	Vanafil Related Compound 1
CAS No.	759408-08-7
Molecular Formula	C23H32N6O4S
Molecular Weight	488.61 g/mol
Synonyms	Vardenafil Related Compound 1; Vardenafil Impurity 1; Vardenafil EP Impurity A; 2-[2-Ethoxy-5-[(4-ethylpiperazin-1-yl)sulfonyl]phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4(3H)-one; Vardenafil N-Oxide Impurity; PDE5 Inhibitor Related Substance
EINECS	Contact for details

Quality Control

Every batch of Vanafil Related Compound 1 is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our standard quality commitment includes comprehensive characterization by HPLC, NMR, and MS. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH and pharmacopeial guidelines. For specific project requirements, custom purity grades and supporting documentation for regulatory submissions are available.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. This material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive). For long-term storage, consider desiccant use and storage under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.